WO2016159493A1 - Biodegradable implant structure - Google Patents

Abstract

The present invention relates to a biodegradable implant structure and, more particularly, to a biodegradable implant structure in which a bioabsorbable metal marker is insertedly installed in a screw and a plate formed of biodegradable polymer so that the mechanical strength of the structure is improved, and at the same time, radiation observation can be performed.

Description

Biodegradable Implant Structure

The present invention relates to a biodegradable implant structure, and more particularly, to a biodegradable implant structure in which a bioabsorbable metal marker is inserted into a plate and a screw made of a biodegradable polymer to improve the mechanical strength of the structure and simultaneously observe the radiation. will be.

Representative materials for implants that are generally used for medical treatment are metal materials with excellent mechanical properties and processability. However, despite the excellent properties of metals, there are some problems, such as stress shielding, image degradation, implant migration, and the like.

In order to overcome such drawbacks of metallic implants, research and development of biodegradable implants has been proposed. Medical applications of such biodegradable materials have been studied mainly from polymers such as polylactic acid (PLA), polyglycolic acid (PGA), or copolymers thereof.

However, the biodegradable polymers have been limited in application due to low mechanical strength, acid generation problem during decomposition, difficulty in controlling biodegradation rate, and the like. My application in dental implants was difficult.

Currently, biomaterials that are mainly used as an implantable medical device are largely classified into metals, ceramics, and polymers, and require requirements such as strength, elastic modulus, durability, biostability, and ease of processing.

In addition, radiotransmittance and magnetic permeability for postoperative radiological observation are also important factors. Table 1 is a table showing the compressive strength of the biomaterial to be the basis of strength, durability among the main factors.

characteristic	Bone	Ti alloy	PEEK	HA	PMMA	PLA
Compressive strength (MPa)	130-180	758-1117	120	600	76	50-70

As shown in Table 1, metal materials such as titanium (Ti) and ceramic materials such as Hydroxyapatite (HA) show good effects in early bone union with high strength, but have high elastic modulus and high stress shielding effect. ) Causes osteoporosis or destruction of surrounding bones, and foreign body reaction in vivo due to corrosion and ionization. In addition, most metal materials interfere with the strong magnetism of MRI, making it difficult to track and observe after the procedure.

In addition, ceramic materials such as HA and bioglass have excellent biocompatibility and good compressive strength, but they are brittle and brittle and are very difficult to process. It has been used a lot of polymer material, PEEK, which has a compressive strength to fit and significantly improves its adaptability with the human body.

The PEEK has excellent strength, toughness and chemical stability, and has X-ray permeability. In addition, the glass transition temperature is around 145 degrees, and the melting point is about 330-350 degrees, which is relatively stable to processing heat compared to other polymers. In terms of physical properties, there are advantages that can be expected, but the lack of biodegradability, such as the existing materials, such as the secondary problem of removal surgery cannot be solved.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a biodegradable implant structure in which a bioabsorbable metal marker is inserted into a plate and a screw made of a biodegradable polymer.

In addition, an object of the present invention is to provide a biodegradable implant structure in which a bioabsorbable metal marker is inserted into a plate and a screw made of a biodegradable polymer to improve the strength and durability of the structure.

Technical problems to be solved by the present invention are not limited to the technical problems mentioned above, and other technical problems not mentioned above will be clearly understood by those skilled in the art from the following description. Could be.

A biodegradable implant structure according to the present invention, comprising: a plate formed of a biodegradable resin; A fastening hole penetrating through the plate; A screw inserted into the fastening hole; And a first marker formed of a bioabsorbable metal inside the plate.

By solving the above problems, the biodegradable implant structure of the present invention provides a structure in which a bioabsorbable metal and a biodegradable polymer are combined to improve mechanical strength and impact resistance, and to enable the observation of radiation (X-ray, etc.) observation. It is effective.

In addition, the biodegradable implant structure of the present invention has the effect of providing a biodegradable implant structure that can be applied in a variety of applications, such as orthopedic, dental, cosmetic surgery.

In addition, the biodegradable implant structure of the present invention has the effect of controlling the pH in the body by buffering the pH decrease or increase phenomenon caused by the decomposition of the bioabsorbable metal or biodegradable polymer.

1 is a view showing a biodegradable implant structure according to an embodiment of the present invention.

2 is a view showing a plate of a biodegradable implant structure according to the first embodiment of the present invention.

3 is a view showing a plate of the biodegradable implant structure according to the second embodiment of the present invention.

4 is a view showing a plate of the biodegradable implant structure according to the third embodiment of the present invention.

5 is a view showing a plate of the biodegradable implant structure according to the fourth embodiment of the present invention.

6 is a view showing a plate of the biodegradable implant structure according to the fifth embodiment of the present invention.

7 is a view showing a screw of the biodegradable implant structure according to an embodiment of the present invention.

8 is a view showing various shapes of the biodegradable implant structure according to another embodiment of the present invention.

10. Plate

20. Fastening hole

30. The first marker

40. Screw

50. Second Marker

60. Through hole

Specific matters including the problem to be solved, the solution to the problem, and the effects of the present invention as described above are included in the embodiments and drawings to be described below. Advantages and features of the present invention, and methods for achieving them will be apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings.

In general, metals, bioabsorbable metals or biodegradable polymers used in conventional implant materials have the problems shown in Table 2 below.

division	metal	Bioabsorbable metal	Biodegradable polymer
problem	Stress Shielding Phenomenon Secondary Removal Surgery Inflammation Distortion Prosthesis, Implant Movement	Hydrogen generation (base) Stress shielding Fast decomposition rate	Weak strength acid generation

The biodegradable implant structure of the present invention is a biodegradable implant structure configured by inserting a bioabsorbable metal reinforcing material into a biodegradable polymer to solve the above problems.

In the following the biodegradable implant structure presented above will be described in detail with reference to the drawings.

As shown in FIG. 1, the biodegradable implant structure according to the present invention includes a plate 10 as a body, a fastening hole 20 formed through the plate 10, and a first marker 30 inserted into the plate. It is configured to include a screw 40 is inserted into the fastening hole 20.

First, the biodegradable implant structure according to the present invention is provided with a plate 10. The plate 10 is a body of a biodegradable implant structure, and serves to connect bones.

The plate 10 is generally designed in a plate shape, as shown in FIG.

The plate 10 is composed of a biodegradable polymer. The biodegradable polymer includes at least one of polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (Polylactide-co-Glycolide, PLGA).

The polylactic acid (PLA), polyglycolic acid (PGA), polylactic acid-glycolic acid copolymer (Polylactide-co-Glycolide, PLGA) is clinically approved by the US Food and Drug Administration (FDA) As a synthetic polymer, it has the advantage of being degraded in vivo and having excellent biocompatibility and relatively good processability.

Next, the biodegradable implant structure according to the present invention is provided with a fastening hole 20 formed through the plate 10. The fastening hole 20 is provided with a space for the screw 40 to be described later to penetrate the plate 10, by inserting the screw 40 so that the plate 10 and the bone is fixed do.

As shown in FIG. 3, the number and shape of the fastening holes 20 may be variously designed such as circular, triangular, square, etc., according to the size and shape of the plate 10 and the screw 40. you can change it.

Next, the biodegradable implant structure according to the present invention is provided with a first marker 30 inside the plate 10. The first marker 30 serves to enhance the durability of the plate 10 and to enable radiation observation.

The first marker 30 is composed of at least one of a metal and a metal alloy. The first marker 30 is composed of a metal or a metal alloy to improve the mechanical strength of the prosthetic material.

In particular, when the first marker 30 is made of a bioabsorbable metal, it is possible to decompose in vivo to prevent side effects such as secondary removal surgery, an inflammatory reaction, and the like that occur after the progression of bone fusion during normal metal insertion.

The bioabsorbable metal used in the first marker 30 includes at least one metal or metal alloy of magnesium, calcium, manganese, iron, zinc, silicon, yttrium, zirconium, and gadolinium.

For example, the biodegradable implant structure of the present invention is most preferably using magnesium or magnesium alloy as the bioabsorbable metal.

Magnesium is an inorganic component constituting the human body has no advantages in vivo, has a high strength and biodegradability, light weight and excellent processability.

In addition, the elastic modulus of magnesium is significantly lower than other medical metal materials, there is an advantage to prevent the stress shielding phenomenon, which is one of the failure factors of the metal prosthetics, implants.

When the first marker 30 is made of a metal or a metal alloy, not only the mechanical strength is improved, but also the metal is inserted into the first marker 30 to enable the radiation observation tracking.

In general, implants composed solely of biodegradable polymers are unable to follow up after surgery due to radiation (x-ray, etc.) transmission. This, the first marker 30 made of metal is inserted into the plate 10 to enable radiation observation.

The first marker 30 serves as a criterion for determining whether the position of the plate 10 is correctly positioned through the observation of radiation. In order to utilize this more efficiently, the first marker 30 preferably has a shape such as a linear shape, a plate shape, a column shape, or the like so as to identify a position.

More specifically, the first marker 30 is a linear shape extending in the longitudinal direction of the plate 10, a plate shape formed along the longitudinal direction of the plate, is formed in a direction perpendicular to the plate 10 It is composed of at least one of the columnar shape.

Hereinafter, the shape of the first marker 30 and its effects will be described in detail using the first embodiment, the second embodiment, the third embodiment, the fourth embodiment, and the fifth embodiment.

(First embodiment)

As shown in FIG. 2, in the first embodiment, the first marker 30 is provided in a linear shape. In the first embodiment, the first marker 30 is provided in a linear shape, so that the insertion position and the equilibrium of the implant structure can be confirmed.

In addition, the first marker 30 provided in the linear shape is preferably provided in two or more linear so as to more accurately observe the position and equilibrium when the radiation is observed.

In addition, as shown in (B) of FIG. 2, the plate 10 may be provided in various shapes such as a curved line and a curved line.

(Second embodiment)

As shown in FIG. 3, in the second embodiment, the first marker 30 is provided in a plate shape. In the second embodiment, the first marker 30 is provided in a plate shape along the longitudinal direction of the plate 10, so that the position and equilibrium of the inserted implant structure can be confirmed.

(Third Embodiment)

As shown in FIG. 4, in the third embodiment, the first marker 30 is provided by combining horizontal and vertical line shapes along the length direction of the plate 10. The first marker 30 is formed to cross the horizontal and vertical lines in the plate 10, the position and the equilibrium can be confirmed in the horizontal direction, to improve the durability by reinforcing the plate 10 Make it work.

(Example 4)

As shown in FIG. 5, in the fourth embodiment, the first marker 30 is provided in a vertical column shape with respect to the side surface of the plate 10 to support both ends of the plate 10. It is provided in the form of reinforcement. The above and the fourth embodiment may be variously designed and modified as long as it can perform the reinforcement role in the vertical direction such as the cylindrical shape of (H) or the cylindrical shape including the hollow part (I) as shown in FIG. Check the insertion position and equilibrium.

(Example 5)

As shown in FIG. 6, in the fifth embodiment, the first marker 30 is provided in the horizontal direction and the vertical direction in combination to support and reinforce the plate 10 and at the same time the contact surface with the plate 10. By widening the stress distribution applied to the plate 10 and the first marker 30 can be made smoothly.

In addition, as shown in (J) of FIG. 6, the first marker 30 is attached to the upper and lower surfaces of the plate 10, and the outer surface which is in contact with the exposure of the first marker 30 due to the decomposition of the plate 10. By widening the contact surface with, the stress applied to the contact surface can be dispersed.

In general, the biodegradable polymer constituting the plate 10 has a sharp drop in strength may cause durability problems. This, by inserting the first marker 30 in the mold portion 10 to reinforce the body plate 10 to improve the durability, mechanical strength.

The first marker 30 is inserted into the plate 10 as described above. This structure has the effect of slowing down the decomposition rate of the fast absorbing bioabsorbable metal.

In general, the bioabsorbable metal has a very rapid corrosion and decomposition rate, so that when exposed to the outside, the bioabsorbable metal decomposes faster than the plate 10, so that it is difficult to perform a role of reinforcing the plate 10. This, the plate 10 made of a biodegradable polymer encapsulates the first marker 30 to protect from the outside has the effect of slowing down the decomposition rate of the bioabsorbable metal.

In addition, the acid generated from the biodegradable polymer when the plate 10 is decomposed and the base generated from the bioabsorbable metal of the first marker 30 is combined and neutralized.

More specifically, the bioabsorbable metal generates various problems such as the generation of a large amount of hydrogen due to the decomposition reaction, the inflammation caused by the increase in pH, and the necrosis of surrounding tissues. On the other hand, biodegradable polymers may cause a large amount of acid during the decomposition reaction to cause harmful effects on the human body. By combining the biodegradable polymer and the bioabsorbable metal, it has an effect of increasing the safety in the body through neutralization.

Next, the biodegradable implant structure according to the present invention is provided with a screw 40. The screw 40 is inserted into the fastening hole 20 and coupled to the plate 10.

In addition, the screw 40 is inserted into the fastening hole 20 and is inserted and fixed to the spine, and serves to fix the biodegradable implant structure and the spine of the present invention, it is made of a biodegradable polymer.

The screw 40 has a variety of three-dimensional structures, such as rod-shaped, disc-shaped, and polyhedral, and is designed in various ways depending on the size and shape between the fastening hole 20 of the plate 10 and the spine into which the structure is inserted. you can change it.

As shown in FIG. 7, the screw 40 may further include a second marker 50. The second marker 50 is embedded in the screw 40 in a longitudinal line shape, thereby enabling radiological observation of the screw 40.

Therefore, the second marker 50 embedded in the screw 40 may be observed with radiation to confirm whether the insertion position of the screw 40 inserted into the spine is correct.

The position of the second marker 50 can be varied in design according to the purpose of use of the implant structure, as shown in Figure 8 if it can perform a radiological observation role in the screw (40).

Next, the biodegradable implant structure according to the present invention may further include a through hole 60 into which the device can be inserted based on the upper surface of the plate 10.

The through hole 60 penetrates through the plate 10 and serves to insert a medical device into the structure.

The position, size, shape, etc. of the through hole 60 may be changed in design depending on the position at which the implant is inserted and the purpose of the implant structure.

Referring to the action of the biodegradable implant structure having the above configuration,

The biodegradable implant structure basically installs the plate 10 in the bone. At this time, the plate 10 serves as a body of the implant structure.

The biodegradable implant structure is installed by inserting the screw 40 in the fastening hole 20 of the plate 10, it is fixed by fastening it. At this time, the screw 40 is inserted into the fastening hole 20 and inserted into the bone to fix the bone and the implant structure.

When the plate 10 and the screw 40 are fixed to the bone and the radiation observation is performed, the first marker 30 inserted into the plate 10 and the second marker inserted into the screw 40 ( 50) is observed to confirm the insertion position and equilibrium of the implant structure.

After confirming the insertion position of the implant structure, as time passes, the plate 10 and the screw 40 are disassembled. At this time, the first marker 30 and the second marker 50 are inserted into the plate 10 and the screw 40, respectively, and are not exposed to the outside so that no decomposition (absorption) reaction occurs. The new bone grows and connects to the location where the decomposition proceeds.

As the plate 10 and the screw 40, which are biodegradable polymers, continue to be decomposed, the first and second markers 30 and 50, which are inserted into the plate 10 and the screw 40, are inserted into the plate 10 and the screw 40. Exposure occurs.

When the first marker 30 and the second marker 50 are exposed, the plate 10 and the screw 40 may be disassembled, and at the same time, the biomarker of the first marker 30 and the second marker 50 may be removed. Decomposition (absorption) proceeds.

As the plate 10, the screw 40, the first marker 30, and the second marker 50 are completely disassembled, no foreign matter remains in the place where the implant structure is located, and bones are connected.

As such, the technical configuration of the present invention described above can be understood by those skilled in the art that the present invention can be implemented in other specific forms without changing the technical spirit or essential features of the present invention.

Therefore, the above-described embodiments are to be understood as illustrative and not restrictive in all respects, and the scope of the present invention is indicated by the following claims rather than the detailed description, and the meaning and scope of the claims and their All changes or modifications derived from an equivalent concept should be construed as being included in the scope of the present invention.

Claims (6)

1. A plate having a plate-shaped body and formed of a biodegradable resin;

   A fastening hole penetrating through the plate;

   A screw inserted into the fastening hole;

   And a first marker formed of a bioabsorbable metal inside the plate.
2. A plate having a plate-shaped body and formed of a biodegradable resin;

   A fastening hole penetrating through the plate;

   A screw inserted into the fastening hole;

   And a second marker formed of a bioabsorbable metal inside the screw.
3. The method of claim 1,

   The first marker is a biodegradable implant, characterized in that the linear extending in the longitudinal direction of the plate
4. The method of claim 3, wherein

   The first marker is a biodegradable implant, characterized in that at least two or more are located in parallel in the plate
5. The method of claim 1,

   The first marker is a biodegradable implant, characterized in that provided on the plate along the longitudinal direction of the plate
6. The method of claim 1,

   Biodegradable implant structure further comprises; through-holes formed in the plate

Images